BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK DURAHOOK 1/4" HOOK 10 PKG/BX 6 HKS/PKG

    MDR report key: 2192918 · Received July 22, 2011

    Report

    Report Number
    3003898360-2011-00319
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNK IF SAMPLE IS AVAILABLE FOR EVAL, THEREFORE, INVESTIGATION IS INCOMPLETE. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGED: CHILDREN'S HOSPITAL NOTICED THE ELASTICS HAD DETERIORATED AWAY FROM THE HOOKS BEFORE HE OPENED THE PACKAGE. PRODUCT WAS NOT OPENED OR USED. HOSPITAL PAPERWORK SUBMITTED STATES THAT THERE WAS NO PT HARM OR A CLOSE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK DURAHOOK 1/4" HOOK 10 PKG/BX 6 HKS/PKG DURAHOOK GDG TELEFLEX MEDICAL 01C1000235

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK